Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial
Abstract Background Non-erosive reflux disease (NERD) is characterized by typical gastroesophageal reflux symptoms, such as heartburn and regurgitation but an absence of esophageal mucosal damage during upper gastrointestinal endoscopy. Although proton pump inhibitors (PPIs) are the first line thera...
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| Format: | Article |
| Language: | English |
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BMC
2022-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06811-x |
| _version_ | 1811249980138061824 |
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| author | Xia Li Haomeng Wu Beihua Zhang Ting Chen Xiaoshuang Shi Jinxin Ma Jiaqi Zhang Xudong Tang Fengyun Wang |
| author_facet | Xia Li Haomeng Wu Beihua Zhang Ting Chen Xiaoshuang Shi Jinxin Ma Jiaqi Zhang Xudong Tang Fengyun Wang |
| author_sort | Xia Li |
| collection | DOAJ |
| description | Abstract Background Non-erosive reflux disease (NERD) is characterized by typical gastroesophageal reflux symptoms, such as heartburn and regurgitation but an absence of esophageal mucosal damage during upper gastrointestinal endoscopy. Although proton pump inhibitors (PPIs) are the first line therapy, almost 50% of patients with NERD fail to respond to this treatment. Traditional Chinese medicine (TCM) can better relieve the symptoms of NERD. Therefore, a randomized controlled trial (RCT) was designed to investigate the efficiency of TCM granules based on Tongjiang (TJ) methodology combined with PPI step-down therapy for NERD patients who did not respond to PPIs alone. Method This multicentered, double-blinded, RCT with two parallel groups will recruit 174 participants who will be randomized into the TCM granules combined with PPI step-down group (n = 87) and the TCM granules placebo combined with PPI step-down group (n = 87). Both groups of participants will receive 6 weeks of treatment and 4 weeks of follow-up, and all participants will be assessed for related symptoms, mental health status, and quality of life at each visit. The primary outcome measurements include visual analog scale (VAS) for heartburn and regurgitation and the major symptoms scale. The secondary outcome measurements include PPI withdrawal rate, symptom recurrence rate, minor symptoms scale, SF-36, PRO, SAS, SDS, GERD–HRQL, and TCM syndromes scales. Discussion Previous research has shown that TCM is capable to alleviate NERD symptoms. This trial will help to provide a better understanding of the synergistic efficiency of the combination of TCM and PPIs, to explore whether the dosage of PPIs can be reduced after the supplement of TCM granules and to provide a feasible plan to reduce dependencies or withdraw NERD patients from PPIs. The outcome of this trial is expected to reduce the symptom recurrence rates, lessen patients’ physical and psychological burdens, and achieve good social benefits. Trial registration Clinicaltrials.gov NCT04340297. Registered on April 9, 2020 |
| first_indexed | 2024-04-12T15:57:00Z |
| format | Article |
| id | doaj.art-43916c2075784a2f9026deb1aaa38d1a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T15:57:00Z |
| publishDate | 2022-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-43916c2075784a2f9026deb1aaa38d1a2022-12-22T03:26:20ZengBMCTrials1745-62152022-10-0123111210.1186/s13063-022-06811-xTraditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trialXia Li0Haomeng Wu1Beihua Zhang2Ting Chen3Xiaoshuang Shi4Jinxin Ma5Jiaqi Zhang6Xudong Tang7Fengyun Wang8Department of Spleen and Stomach Diseases of Traditional Chinese Medicine, China-Japan Friendship HospitalThe Second Clinical College of Guangzhou University of Chinese MedicineDepartment of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese MedicineDepartment of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese MedicineDepartment of Gastroenterology, The Third Affiliated Hospital of Beijing University of Chinese MedicineDepartment of Gastroenterology, Peking University Traditional Chinese Medicine Clinical Medical School (Xiyuan)Department of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese MedicineChina Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese MedicineDepartment of Gastroenterology, Xiyuan Hospital Affiliated to China Academy of Traditional Chinese Sciences, Beijing Institute of Spleen and Stomach Disease of Traditional Chinese MedicineAbstract Background Non-erosive reflux disease (NERD) is characterized by typical gastroesophageal reflux symptoms, such as heartburn and regurgitation but an absence of esophageal mucosal damage during upper gastrointestinal endoscopy. Although proton pump inhibitors (PPIs) are the first line therapy, almost 50% of patients with NERD fail to respond to this treatment. Traditional Chinese medicine (TCM) can better relieve the symptoms of NERD. Therefore, a randomized controlled trial (RCT) was designed to investigate the efficiency of TCM granules based on Tongjiang (TJ) methodology combined with PPI step-down therapy for NERD patients who did not respond to PPIs alone. Method This multicentered, double-blinded, RCT with two parallel groups will recruit 174 participants who will be randomized into the TCM granules combined with PPI step-down group (n = 87) and the TCM granules placebo combined with PPI step-down group (n = 87). Both groups of participants will receive 6 weeks of treatment and 4 weeks of follow-up, and all participants will be assessed for related symptoms, mental health status, and quality of life at each visit. The primary outcome measurements include visual analog scale (VAS) for heartburn and regurgitation and the major symptoms scale. The secondary outcome measurements include PPI withdrawal rate, symptom recurrence rate, minor symptoms scale, SF-36, PRO, SAS, SDS, GERD–HRQL, and TCM syndromes scales. Discussion Previous research has shown that TCM is capable to alleviate NERD symptoms. This trial will help to provide a better understanding of the synergistic efficiency of the combination of TCM and PPIs, to explore whether the dosage of PPIs can be reduced after the supplement of TCM granules and to provide a feasible plan to reduce dependencies or withdraw NERD patients from PPIs. The outcome of this trial is expected to reduce the symptom recurrence rates, lessen patients’ physical and psychological burdens, and achieve good social benefits. Trial registration Clinicaltrials.gov NCT04340297. Registered on April 9, 2020https://doi.org/10.1186/s13063-022-06811-xNonerosive reflux disease (NERD)TCM granulesPPIRandomized controlled trial (RCT)Protocol |
| spellingShingle | Xia Li Haomeng Wu Beihua Zhang Ting Chen Xiaoshuang Shi Jinxin Ma Jiaqi Zhang Xudong Tang Fengyun Wang Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial Trials Nonerosive reflux disease (NERD) TCM granules PPI Randomized controlled trial (RCT) Protocol |
| title | Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial |
| title_full | Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial |
| title_fullStr | Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial |
| title_full_unstemmed | Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial |
| title_short | Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial |
| title_sort | traditional chinese medicine based on tongjiang methodology combined with proton pump inhibitor ppi step down in treating non erosive reflux disease a study protocol for a multicentered randomized controlled clinical trial |
| topic | Nonerosive reflux disease (NERD) TCM granules PPI Randomized controlled trial (RCT) Protocol |
| url | https://doi.org/10.1186/s13063-022-06811-x |
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